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Form 483

Tiller MIND BODY, Inc. Form 483, 2023-07-13

FDA issued a Form 483 to Tiller MIND BODY, Inc. on 2023-07-13 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Tiller MIND BODY, Inc. · San Antonio, United States · Issued July 13, 2023

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

13 Jul 2023
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Terri E Gibson

13 Jul 2023
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Terri E Gibson

13 Jul 2023
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Terri E Gibson

13 Jul 2023
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Terri E Gibson

13 Jul 2023
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Terri E Gibson

Inspected site

TMTiller MIND BODY, Inc.San Antonio, United States

Inspection team

TETerri E Gibson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(d)Cited across public-safe Form 483 observations2x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere